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Senior Design Assurance Engineer

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Regulatory & Quality Assurance
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418 Total Views
Thanks for your interest in the Senior Design Assurance Engineer position. Unfortunately this position has been closed but you can search our 187 open jobs by clicking here.

Qualifications

Education  

  • Technical Bachelor Degree

Experience 

  • 2-5 years’ experience preferably in medical device industry

Skills

  • Experienced with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
  • Experienced with ISO 14970, Risk Management
  • Experienced with Usability, Reliability, Electrical Safety and Software standards and regulations.
  • Working knowledge of verification and validation requirements for a regulated product
  • Working knowledge of requirements analysis, including development of testable and measurable specifications
  • Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
  • Ability to appropriately assess written product and project documentation as the principle advocate for compliance, and ability to effectively communicate assessment
  • Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiments strongly preferred

Organizational Relationships

  • Works with Divisional and Costa Rica personnel including R&D, Regulatory, Marketing, PMQA, Manufacturing Engineering, and Quality Engineering

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

 

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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